NIGHT TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Night time cold and flu by

Drug Labeling and Warnings

Night time cold and flu by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 15 mL)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves these common cold/flu symptoms:

• minor aches and pains
• headache
• sore throat
• fever
• runny nose and sneezing
• itchy nose or throat
• coughs
• cough due to minor throat and bronchial irritation

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using this product

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

• to make a child sleepy
• if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
• if you are allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if you have

• liver disease
• glaucoma
• breathing problems
• chronic bronchitis
• a sodium-restricted diet
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma or emphysema or if cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are taking

• sedatives or tranquilizers
• the blood thinning drug warfarin

When using this product

• do not use more than directed (see overdose warning)
• excitability may occur, especially in children
• marked drowsiness may occur
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• redness or swelling is present
• new symptoms occur
• fever gets worse or last more than 3 days
• pain or cough gets worse or last more than 7 days
• cough comes back or occurs with rash or headache that lasts.

These could be a signs of a serious conditions.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

• take only as recommended (see overdose warning)
• do not exceed 4 doses per 24 hours
• use dosing cup provided
• mL= milliliter

• age: dose
• adults & children 12 yrs and over: 30 mL every 6 hours
• children 4 to 11 yrs: do not use unless directed by a doctor
• children under 4 yrs: do not use

• When using Day Time or Night Time products, carefully read each label to ensure correct dosing.

Other information

• each 15 mL contains; sodium 18 mg
• store at room temperature

Inactive ingredients

alcohol, citric acid. FD&C blue1, FD&C red 40, Flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

 Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to active ingredients in Vicks® NyQuil®*

night time

cold & flu

Acetaminophen

dextromethorphan HBr

doxylamine succinate

relieves:

• aches, fever & sore throat
• cough
• runny nose & sneezing

for ages 12 & over

alcohol 10%

Cherry flavor

FL OZ (mL)

*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® and NyQuil® are registered trademarks of The procter & Gamble Company.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.

Manufactured by:

PL Developments

11865 S. Alameda St

Lynwood, CA 90262

Product Label

ReadyinCase NightTime Cold & Flu Cherry Liquid

INGREDIENTS AND APPEARANCE

NIGHT TIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49580-0342
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49580-0342-1	296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/28/2015
2	NDC: 49580-0342-2	355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/28/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	02/28/2015

Labeler - P & L Development, LLC (101896231)